WO2004073518A1 - Capteur du sphincter de l'oesophage - Google Patents

Capteur du sphincter de l'oesophage Download PDF

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Publication number
WO2004073518A1
WO2004073518A1 PCT/GB2004/000638 GB2004000638W WO2004073518A1 WO 2004073518 A1 WO2004073518 A1 WO 2004073518A1 GB 2004000638 W GB2004000638 W GB 2004000638W WO 2004073518 A1 WO2004073518 A1 WO 2004073518A1
Authority
WO
WIPO (PCT)
Prior art keywords
sensor
sphincter
data
closure sensor
electrodes
Prior art date
Application number
PCT/GB2004/000638
Other languages
English (en)
Inventor
Diana Hodgins
Joseph Mark Hatt
Original Assignee
European Technology For Business Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by European Technology For Business Limited filed Critical European Technology For Business Limited
Publication of WO2004073518A1 publication Critical patent/WO2004073518A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/22—Ergometry; Measuring muscular strength or the force of a muscular blow
    • A61B5/224—Measuring muscular strength
    • A61B5/227—Measuring muscular strength of constricting muscles, i.e. sphincters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0247—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1107—Measuring contraction of parts of the body, e.g. organ, muscle

Definitions

  • This invention relates to a sensor for detecting correct closure of a sphincter associated with a body duct.
  • the invention is concerned with a sensor for closure of the lower oesophageal sphincter (LOS) of a human body.
  • the invention further relates to a sphincter sensor system including a control module external of a body in which the sensor is located, at least to record data from the sensor.
  • GORD gastro-oesophageal reflux disease
  • GORD Factors that are believed to cause GORD include: transient lower oesophageal sphincter relaxations, decreased LOS resting tone, delayed stomach emptying, and ineffective oesophageal clearance.
  • One primary cause of gastro-oesophageal reflux disease is the lack of competency of the lower oesophageal sphincter.
  • the lower oesophageal sphincter or valve is comprised of both smooth and skeletal muscle located at the gastro-oesophageal junction.
  • Tests can be carried out on patients to determine the competency of the
  • a multi-lumen catheter is introduced through the naso-gastric passage into the stomach.
  • the lumens are closed at the lower end and each one has a pressure port on the side of the catheter.
  • the individual lumen ports are arranged along the length and around the circumference of the catheter to allow the study of pressure variations in the oesophagus and lower oesophageal sphincter.
  • the pressure at each port is determined by using a pneumo-hydraulic pump to perfuse water through the lumen, and measuring the pump pressure required.
  • the water perfusion improves the fidelity of the readings compared to static water-filled lumen pressure measurement, since the effect of catheter elasticity is to incur a negligible time delay rather than to attenuate the pressure readings.
  • Catheters vary in diameter from 2 to 5mm for oesophageal use, and number of ports from 1 to 8. • Solid state catheters. Solid-state catheters are arranged with a similar spread of radial and axial pressure reading positions as are found on water-perfused catheters. The pressure is read directly by solid-state strain gauge sensors deposited on metal diaphragms placed on the body of the catheter, and these can be either directional (radial) or circumferential.
  • the sensors are not sensitive to inclination and movement, unlike water-perfused catheters, and require much less calibration.
  • the electrical signals are carried by wires, routed through the naso-gastric passage, and can be continuously recorded away from the clinical environment.
  • Solid-state catheters allow 24-hour ambulatory studies to be conducted. Patients are encouraged to follow a relatively normal routine, including meals, during the 24-hour study, so the shape and size of the solid-state catheters is important to avoid blockages of the oesophagus.
  • the catheter is usually between 2 and 3mm diameter and smooth.
  • Both of the above devices measure pressure at discrete points around the sphincter. However, the requirement is to determine whether the sphincter has closed all the way around, and not what the pressure is at discrete points.
  • This proposed new system of this invention monitors the movement of the sphincter around its inner circumference, thus more readily matching the need of clinicians. Whilst eight measuring points around the circumference are proposed initially, perhaps arranged in three rows each of eight measuring points, this could be increased if an increased resolution is required.
  • the proposed sensor should be sized to allow insertion through a standard endoscope.
  • a principal aim of this invention is the provision of a micro-fabricated sensor that can detect whether a sphincter (human valve) is closing correctly.
  • one aspect of this invention provides sphincter closure sensor for the remote monitoring of the closing action of a human sphincter muscle, comprising a micro-fabricated electrode array formed on a flexible substrate which is in use deformed by the action of a sphincter muscle with which the sensor is associated, a control circuit connected lo the electrodes to produce an electrical data output, and a data link to permit the transfer of electrical signals to and from the circuit with respect to a location remote from the substrate.
  • a sensor of this invention includes a micro-fabricated electrode array on a flexible substrate, micro-connections to a control circuit which might include a multiplexer, and a data link for signals from the sensor, which data link typically may have a micro-fabricated RF coil or may comprise a hard-wired data cable.
  • the assembly may be coated in a suitable inert biomaterial for insertion in the human body, and be activated externally.
  • the complete micro-system may be used for diagnosis in hospital clinics, and could be linked to a local body area network (BAN).
  • BAN local body area network
  • a prime specific medical application for the device is to determine whether the lower oesophageal sphincter (LOS) is closing properly.
  • the sensor would be located within the body to extend through the LOS, an external data recorder being connected to a BAN.
  • the sensor may be a disposable device and work for up to 24 hours in the body, without any maintenance during this period. It should also be of low cost, in order that it can be widely utilised.
  • the sensor must be compliant in order to fit through the nose or throat passage, before being located in the sphincter region. It must also be coated with a biocompatible material to stop bacterial growth and prevent malfunction or injury to the patient. When the LOS is open, the sensor must allow the passage of food and liquid into the stomach without damage to the sensor. The sensor should thus be very small (02mm or less) in order not to affect the flow of food and liquid, nor the closure of the sphincter. Ideally, it may be inserted by a nurse or doctor at an outpatient clinic, and may also be sufficiently small to pass through a standard endoscope.
  • a typical specification for a sensor of this invention might be:
  • Insertion using a catheter or endoscope, with an oesophageal clip to retain the sensor Note: The sensor is likely to be too long to pass through the patient after the recording period, so must be retrieved by the tether.
  • MST will be combined with biomaterials, low power electronics, a miniature power source and RF communications in order to achieve this overall objective.
  • biomaterials low power electronics, a miniature power source and RF communications.
  • an embodiment of the invention has:
  • a sensor mechanism - micro-electrodes are micro-fabricated on to a cylindrical structure. This will be of a highly compliant material including foamed elastomers or a compliant structure in the form of an elongate balloon. The balloon would be internally pressurised during use to increase the compliance of the sensor above that of the parent materials.
  • a biomaterial coating - the sensor assembly is coated with a biomaterial that allows the passage of food and liquids, without being damaged or harming the patient.
  • a miniature multiplexer - in order to reduce the number of data transfer channels the electrode outputs will be multiplexed, within an electronics/RF enclosure. • An RF receiver unit.
  • a sphincter closure sensor system for detecting closure of a body sphincter muscle which system comprises:
  • a sphincter closure sensor as claimed in any of the preceding claims and adapted for positioning within a body duct so as to be surrounded by a sphincter muscle;
  • Figure 1 conceptually shows a balloon and core of the sensor
  • Figures 2A and 2B diagrammatically illustrate the micro-electrode structure for the balloon and core of Figure 1 ;
  • Figure 3 illustrates the use of the sensor within a lower oesophageal sphincter of a patient
  • Figures 4A and 4B show block diagrams of alternative arrangements for the oesophageal sensor and external control unit.
  • the sensor comprises a conductive central core electrode 10, able to serve as a reference electrode for the sensor.
  • This core electrode 10 is surrounded by a flexible sheet 11 having a plurality of micro- fabricated linear electrodes 12 formed thereon ( Figures 2A and 2B), the flexible sheet 11 being carried on the inner surface of an outer highly compliant tubular balloon 13 or other tubular structure.
  • the annular space 14 between the core electrode 10 and the tubular balloon 13 is closed at its ends and is filled with a fluid under pressure. Individual connections are made to the linear electrodes and the capacitance between each linear electrode and the core electrode 10 is determined.
  • the balloon When the sensor is located in a sphincter ( Figure 3) and the sphincter closes, the balloon will be squeezed as shown by arrow A, reducing the gap between sheet 11 and the core electrode 10 as shown at 15 and so altering the capacitances between the linear electrodes and the core electrode.
  • the capacitances are determined and are multiplexed together, for supply to an external datalogger.
  • the balloon 13 is fabricated from a material that can be inflated by the fluid in the annular space 14 and has, in this embodiment, a wall thickness of approximately 100 microns.
  • the balloon has sufficient strength to withstand the external forces from the sphincter and from food and liquid.
  • the balloon typically might be of siiicone rubber and the core electrode 10 of a metal or other conductive material.
  • the electrodes 12 disposed within the balloon 13 are patterned on to polyamide strip, or on to a similar flexible circuit material as shown in Figures 2A and 2B.
  • the electrodes 12 may be arranged in three rows along the axis of sensor, with interconnect electrodes 16 between the rows. Each electrode set is trimmed typically into twelve strips of electrodes, to allow expansion of the siiicone rubber balloon.
  • the fabrication of the flexible circuits allows for the build-up of multiple layers, including a thin insulating dielectric layer to separate the electrodes from the central core of the sensor. Typical flexible electrode circuit designs are shown in Figures 2A and 2B.
  • the coating of the sensor is critical in that it must not encourage bacterial growth whilst immersed in food or liquid which passes into the stomach, and must be compliant enough to be passed through the oesophagus to the LOS, and yet withstand the force from the sphincter.
  • the nano structure of certain materials may be modified to stop bacterial growth, either chemically or physically.
  • the external form of the compliant biomaterial moulded over the exterior of the sensor must not cause damage to the sphincter when it closes on to the sensor.
  • a control circuit is formed as a part of the sensor.
  • the structure of the core electrode and the balloon 13 is elongate and of a relatively small diameter.
  • a housing 18 within which is disposed the control circuit, to which the individual linear electrodes 12 and the core electrode 10 are connected.
  • That circuit includes a multiplexer in order to combine together the output of the linear electrodes. Typically, there may be seventy two such linear electrodes the outputs of which are to be combined by the multiplexer, to reduce the number of channels to be monitored.
  • Actual embodiments of the sensor may have fewer or more than 72 linear electrodes, depending upon the design and the length of the core electrode and surrounding balloon.
  • the control circuit further comprises an RF coil, both for transmitting the output of the control circuit to an external monitor, and for receiving electrical energy from that external monitor to power the device.
  • the joining of the electrodes to the control circuit including the multiplexer and also the RF coil may be achieved by true 3D micro-fabrications.
  • Overall Svstem Figure 4A shows one embodiment of a complete system which comprises the sensor balloon assembly, the control circuit including the multiplexer and RF coil, and an external module to record the sensor output.
  • Recording of the sensor output may be achieved by the external module including a timer circuit which supplies power to the sensor, to trigger a reading cycle to obtain data therefrom, typically at 8Hz.
  • the power supply should be housed in an external module fitted to the patient.
  • This module includes the transmitter unit, a datalogger, and a rechargeable power supply.
  • the datalogger of the external module may link to a body area network (BAN).
  • the internal sensor unit may then comprise the receiver and any passive components required to drive the sensor.
  • a hard-wired link is provided between the sensor and the external module.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Ce capteur 13 de télésurveillance de l'action de fermeture d'un muscle sphincter humain comprend une rangée de microélectrodes 12 formée sur un substrat flexible 11 qui, en utilisation, est déformé par l'action d'un muscle sphincter. Le substrat 11 encercle une électrode centrale 10 et les fluctuations de la capacitance des électrodes est captée afin de générer une sortie électrique de données. Une liaison RF multiplexée vers un module extérieur permet de surveiller la sortie du capteur.
PCT/GB2004/000638 2003-02-18 2004-02-17 Capteur du sphincter de l'oesophage WO2004073518A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0303693.6 2003-02-18
GB0303693A GB0303693D0 (en) 2003-02-18 2003-02-18 Oesophageal sphincter sensor

Publications (1)

Publication Number Publication Date
WO2004073518A1 true WO2004073518A1 (fr) 2004-09-02

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PCT/GB2004/000638 WO2004073518A1 (fr) 2003-02-18 2004-02-17 Capteur du sphincter de l'oesophage

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GB (1) GB0303693D0 (fr)
WO (1) WO2004073518A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006090351A1 (fr) * 2005-02-21 2006-08-31 Diagles Ltd Procede et dispositif permettant de mesurer mecaniquement des sphincters et des regions retrecies dans des organes biologiques creux
WO2020092708A1 (fr) * 2018-10-31 2020-05-07 Stryker Corporation Système et procédé pour surveiller l'activité nerveuse à l'intérieur d'une trachée d'un patient

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3006620A1 (de) * 1980-02-22 1981-09-03 Robert Bosch Gmbh, 7000 Stuttgart Beruehrungssensor
US4873990A (en) * 1988-09-23 1989-10-17 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Circumferential pressure probe
DE4134116A1 (de) * 1991-10-15 1993-04-22 Peter Seitz Verfahren zur analyse des funktionszustandes von muskeln an oder in koerperoeffnungen
US5533515A (en) * 1994-08-11 1996-07-09 Foster-Miller Solid state sphincter myometers
US6285897B1 (en) * 1999-04-07 2001-09-04 Endonetics, Inc. Remote physiological monitoring system

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3006620A1 (de) * 1980-02-22 1981-09-03 Robert Bosch Gmbh, 7000 Stuttgart Beruehrungssensor
US4873990A (en) * 1988-09-23 1989-10-17 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Circumferential pressure probe
DE4134116A1 (de) * 1991-10-15 1993-04-22 Peter Seitz Verfahren zur analyse des funktionszustandes von muskeln an oder in koerperoeffnungen
US5533515A (en) * 1994-08-11 1996-07-09 Foster-Miller Solid state sphincter myometers
US6285897B1 (en) * 1999-04-07 2001-09-04 Endonetics, Inc. Remote physiological monitoring system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006090351A1 (fr) * 2005-02-21 2006-08-31 Diagles Ltd Procede et dispositif permettant de mesurer mecaniquement des sphincters et des regions retrecies dans des organes biologiques creux
WO2020092708A1 (fr) * 2018-10-31 2020-05-07 Stryker Corporation Système et procédé pour surveiller l'activité nerveuse à l'intérieur d'une trachée d'un patient

Also Published As

Publication number Publication date
GB0303693D0 (en) 2003-03-19

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